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Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00374335
Recruitment Status : Completed
First Posted : September 11, 2006
Results First Posted : September 12, 2011
Last Update Posted : September 16, 2011
Sponsor:
Collaborators:
Medical College of Wisconsin
University of California, San Francisco
Columbia University
Baylor College of Medicine
Northwestern University
St. Justine's Hospital
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Tracking Information
First Submitted Date  ICMJE September 7, 2006
First Posted Date  ICMJE September 11, 2006
Results First Submitted Date  ICMJE August 9, 2011
Results First Posted Date  ICMJE September 12, 2011
Last Update Posted Date September 16, 2011
Study Start Date  ICMJE September 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
  • Frequency of Hepatic Hemangiomas Identified on Abdominal Ultrasound [ Time Frame: 2 years ]
    The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound
  • Presence of Hepatic Hemangiomas on Abdominal Ultrasound [ Time Frame: 2 years ]
    The number of participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least one large cutaneous hemangioma) who were found to have hepatic hemangiomas on abdominal ultrasound
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
Presence of Hepatic Hemangiomas on Abdominal Ultrasound
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2011)
Risk Factors Associated With the Development of Hepatic Hemangiomas [ Time Frame: 2 years ]
Which participants with cutaneous infantile hemangiomas (1-4 cutaneous hemangiomas, greater than 5 cutaneous hemangiomas, or at least 1 large cutaneous hemangioma) were found to have hepatic hemangiomas on abdominal ultrasound
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2006)
identify risk factors associated with the development of hepatic hemangiomas
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Incidence of Hepatic Hemangiomatosis in Patients With Cutaneous Hemangiomas
Official Title  ICMJE Multiple Hemangiomas and Large Cutaneous Hemangiomas of Infancy: Incidence of Hepatic Hemangiomatosis
Brief Summary This study will attempt to determine how common liver hemangiomas are in children with infantile hemangiomas by comparing liver ultrasound results in patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma versus ultrasound results in children without hemangiomas. Other objectives of the study include identifying specific risk factors in patients who have liver hemangiomas and identifying risk factors in children with symptomatic liver hemangiomas.
Detailed Description

Hemangioma of infancy is the most common tumor of childhood occurring in 4% to 10% of infants. While most hemangiomas are benign in behavior and involute spontaneously, some can cause significant morbidity due to their location and size. In addition, some hemangiomas may be associated with extracutaneous hemangiomas that result in significant morbidity. Certain "high risk" hemangiomas of infancy, specifically multiple cutaneous hemangiomas or a solitary large hemangioma, have been associated with hepatic hemangiomatosis; however, the exact number or size of the cutaneous lesions at which the risk increases and the protocol for evaluating these patients remain controversial. The true prevalence of hepatic hemangiomatosis is unknown since there have been no large scale prospective studies evaluating clinically asymptomatic patients with cutaneous hemangiomas for the presence of hepatic hemangiomatosis.

One of the primary objectives of this study is to determine the incidence of hepatic hemangiomatosis in patients with hemangiomas of infancy by comparing hepatic ultrasound imaging results of patients with 1-4 cutaneous hemangiomas, 5 or more cutaneous hemangiomas, or at least 1 large hemangioma >30 cm2 versus imaging results in patients without cutaneous hemangiomas. The study will also attempt to identify specific risk factors associated with the development of hepatic hemangiomatosis and to identify associated risk factors in patients with clinically symptomatic hepatic hemangiomatosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Hemangioma
Intervention  ICMJE
  • Procedure: abdominal ultrasound
    abdominal ultrasound to detect hepatic hemangiomas
  • Other: Dermatologic Examination
    Complete dermatologic examination
Study Arms  ICMJE infants with cutaneous hemangiomas
Interventions:
  • Procedure: abdominal ultrasound
  • Other: Dermatologic Examination
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2011)
261
Original Enrollment  ICMJE
 (submitted: September 8, 2006)
325
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants less than 6 months of age
  • clinical diagnosis of 1-4 cutaneous hemangiomas
  • clinical diagnosis of 5 or more cutaneous hemangiomas
  • clinical diagnosis of at least 1 large cutaneous hemangioma greater than 30 cm2

Exclusion Criteria:

  • Infants greater than 6 months of age
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00374335
Other Study ID Numbers  ICMJE 06 02 029E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Children's Mercy Hospital Kansas City
Study Sponsor  ICMJE Children's Mercy Hospital Kansas City
Collaborators  ICMJE
  • Medical College of Wisconsin
  • University of California, San Francisco
  • Columbia University
  • Baylor College of Medicine
  • Northwestern University
  • St. Justine's Hospital
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators  ICMJE
Principal Investigator: Beth A Drolet, MD Medical College of Wisconsin
Principal Investigator: Maria Garzon, MD Columbia University
Principal Investigator: Kimberly A Horii, MD Children's Mercy Hospital Kansas City
Principal Investigator: Denise Metry, MD Baylor College of Medicine
Principal Investigator: Sarah Chamlin, MD Northwestern University-Children's Memorial Hospital
Principal Investigator: Ilona J Frieden, MD University of California, San Francisco
Principal Investigator: Julie Powell, MD St. Justine's Hospital
Principal Investigator: Anne Lucky, MD Children's Hospital of Cincinnati
Principal Investigator: Eulalia Baselga, MD Hospital de la Santa Crue i Santa Pau
PRS Account Children's Mercy Hospital Kansas City
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP